A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis
NCT ID: NCT05377580
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2022-07-01
2025-08-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis
NCT07035041
A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
NCT03675477
A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis
NCT01551290
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
NCT07229950
A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis
NCT01959282
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Period 2 IBI112 dose 4
Period 2 IBI112 dose 4
Intravenous Injection
Period 1 IBI112 Placebo
Period 1 IBI112 Placebo
Intravenous Injection
Period 2 IBI112 dose 3
Period 2 IBI112 dose 3
Subcutaneous injections
Period 2 IBI112 Placebo
Subcutaneous injections
Period 1 IBI112 dose 2
Period 1 IBI112 dose 2
Intravenous Injection
Period 2 IBI112 Placebo
Period 2 IBI112 Placebo
Subcutaneous injections
Period 1 IBI112 dose 1
Period 1 IBI112 Placebo
Intravenous Injection
Period 1 IBI112 dose 1
Intravenous Injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Period 1 IBI112 Placebo
Intravenous Injection
Period 2 IBI112 dose 3
Subcutaneous injections
Period 1 IBI112 dose 1
Intravenous Injection
Period 1 IBI112 dose 2
Intravenous Injection
Period 2 IBI112 dose 4
Intravenous Injection
Period 2 IBI112 Placebo
Subcutaneous injections
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with moderate to severe ulcerative colitis, defined as modified Mayo Score ≥4 and endoscopic score ≥2;
3. Subject must have received at least one prior treatment or first use of a biological agent:
Exclusion Criteria
2. UC lesions were limited to rectum or involved colon \< 15cm;
3. Evidence of toxic hirschsprung's disease was found during screening;
4. History or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIBI112B201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.